VistaGen Therapeutics(VTGN) - 2025 Q2 - Quarterly Results

Financial Performance - Net loss for Q2 FY2025 was $13.0 million, compared to a net loss of $6.6 million in Q2 FY2024[6]. - Total revenues for the three months ended September 30, 2024, were $183,000, a decrease of 34.2% compared to $278,000 for the same period in 2023[17]. - The net loss for the three months ended September 30, 2024, was $12,961,000, compared to a net loss of $6,588,000 for the same period in 2023, representing a 96.0% increase in losses[17]. - Comprehensive loss for the three months ended September 30, 2024, was $12,941,000, compared to $6,588,000 in the same period last year, indicating a 96.0% increase[17]. - Basic and diluted net loss per common share was $(0.42) for the three months ended September 30, 2024, an improvement from $(0.66) in the prior year[17]. Expenses - Research and development (R&D) expense increased to $10.2 million for Q2 FY2025, up from $3.9 million in Q2 FY2024, primarily due to expenses related to the PALISADE Phase 3 Program for fasedienol[5]. - General and administrative (G&A) expense rose to $4.2 million for Q2 FY2025, compared to $3.2 million in Q2 FY2024, driven by increased headcount and professional service fees[6]. - Total operating expenses for the three months ended September 30, 2024, were $14,410,000, a significant increase of 104.1% from $7,058,000 in the prior year[17]. - Research and development expenses increased to $10,215,000 for the three months ended September 30, 2024, up 165.5% from $3,851,000 in the prior year[17]. - General and administrative expenses rose to $4,195,000 for the three months ended September 30, 2024, compared to $3,207,000 in the same period last year, reflecting a 30.8% increase[17]. Assets and Cash Position - Cash, cash equivalents, and marketable securities totaled $97.6 million as of September 30, 2024[7]. - Vistagen's total assets decreased to $102.5 million as of September 30, 2024, down from $123.7 million as of March 31, 2024[14]. Clinical Development - The PALISADE-3 and PALISADE-4 Phase 3 trials for fasedienol are on track to produce top-line results in 2025[4]. - Vistagen is preparing for Phase 2B development of itruvone, targeting major depressive disorder without the side effects of current therapies[4]. - The ongoing IND-enabling program for PH80 aims to support its submission for Phase 2 clinical development as a hormone-free treatment for menopausal hot flashes[4]. - Fasedienol is positioned as a potential first-in-class treatment for social anxiety disorder, with Fast Track designation from the U.S. FDA[8]. - Itruvone has also received Fast Track designation for major depressive disorder, highlighting its novel mechanism of action[9]. Shareholder Information - Weighted average common shares outstanding increased to 30,632,347 for the three months ended September 30, 2024, compared to 10,042,530 in the same period last year[17]. Other Financial Metrics - Interest income for the three months ended September 30, 2024, was $1,273,000, a substantial increase from $192,000 in the prior year[17]. - The company reported an unrealized gain on marketable securities of $20,000 for the three months ended September 30, 2024, compared to no gain in the prior year[17].